Leflunomide
Also known as: Arava · Leflunomide Zentiva (previously Leflunomide Winthrop) · Leflunomide medac · Leflunomide ratiopharm
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a disease-modifying antirheumatic drug, as well as for active psoriatic arthritis. In the United States, leflunomide tablets are a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. In the European Union, recent or concurrent treatment with hepatotoxic or haematotoxic disease-modifying antirheumatic drugs, such as methotrexate, may increase the risk of serious adverse reactions, and switching to another disease-modifying antirheumatic drug without a washout procedure may also increase this risk.
From: Source: European Medicines Agency (EMA), Arava — EPAR, 07/09/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 27169 leflunomide
- EMA
- EMEA/H/C/000235, EMEA/H/C/001129, EMEA/H/C/001227, EMEA/H/C/002035
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Arava
Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Source: European Medicines Agency (EMA), Arava — EPAR, 07/09/2026. © European Medicines Agency.
Document date: 07/09/2026 · Official document →
FDA (USA) leflunomide
1 INDICATIONS AND USAGE Leflunomide tablets is indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide tablets are a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.
Data provided by the U.S. Food and Drug Administration.
Document date: 20260317 · Official document →
EMA (EU) Leflunomide Zentiva (previously Leflunomide Winthrop)
Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Source: European Medicines Agency (EMA), Leflunomide Zentiva (previously Leflunomide Winthrop) — EPAR, 22/09/2026. © European Medicines Agency.
Document date: 22/09/2026 · Official document →
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Leflunomide approved for in the European Union?
Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD); active psoriatic arthritis. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching. (Source: European Medicines Agency (EMA), Arava — EPAR, 07/09/2026. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Arava — EPAR, 07/09/2026. © European Medicines Agency.
- Source: European Medicines Agency (EMA), Leflunomide Zentiva (previously Leflunomide Winthrop) — EPAR, 22/09/2026. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
In an emergency, call 112 (or your local emergency number). Do not delay seeking medical help because of something you read here.